NCT00005647

SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck

A Phase I Pharmacokinetic, Pharmacodynamic, and Clinical Study of the Combination of the Angiogenesis Inhibitor SU5416 and Paclitaxel in Recurrent or Metastatic Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: SU5416 may stop the growth of head and neck cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of SU5416 and paclitaxel in treating patients who have recurrent, locally advanced, or metastatic cancer of the head and neck.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose and safety of SU5416 and paclitaxel in patients with recurrent or metastatic head and neck cancer. * Determine the antiangiogenesis effect of this combination regimen in these patients. * Determine the toxicity, pharmacodynamic effects, and pharmacokinetic parameters of this combination. OUTLINE: This is a dose escalation study. Patients receive paclitaxel IV over one hour on day 1 and SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel and SU5416 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities. PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study within 9-15 months.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	paclitaxel	Patients receive paclitaxel IV over one hour on day 1. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.
DRUG	semaxanib	Patients receive SU5416 IV over one hour on days 1 and 4. Treatment continues weekly in the absence of disease progression or unacceptable toxicity.

Timeline

• Start date: 2000-05-01
• Primary completion: 2002-12-01
• Completion: 2003-10-01
• First posted: 2003-01-27
• Last updated: 2010-06-10

Locations

1 site across 1 country: United States